BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 281268 · Received June 9, 2000

    Report

    Report Number
    1823260-2000-00112
    Event Type
    Death
    Date Received
    June 9, 2000
    Date of Event
    May 9, 2000
    Report Date
    May 10, 2000
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT TESTED BLOOD GLUCOSE ON THE SUSPECT DEVICE AT 2:43PM AND IT WAS 346 MG/DL. PT FELT DIZZY AND WAS HOT. THE PARAMEDICS WERE CALLED AND AT 3:30-3:45 PM, THEY TESTED PT'S BLOOD GLUCOSE ON THEIR DEVICE AND IT WAS 32 MG/DL. PT WAS GIVEN A VIAL OF DEXTROSE AND TAKEN TO THE HOSP. WHILE IN THE HOSP, THE CUSTOMER PASSED AWAY. PER THE RPTR, THE CAUSE OF DEATH WAS RESPIRATORY PROBLEMS, FLUID BUILD UP AND KIDNEY FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE BLOOD GLUCOSE MONITORING TEST STRIPS CFR ROCHE DIAGNOSTICS NA 533872

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death